Enzyme-Linked Immunosorbent Assay Screening Then Indirect Immunofluorescence Confirmation of Antinuclear Antibodies A Statistical Analysis

被引：42

作者：

Copple, Susan S.

Sawitzke, Allen D. ^{[1
]}

Wilson, Andrew M. ^{[2
]}

Tebo, Anne E. ^{[2
,3
]}

Hill, Harry R. ^{[2
,3
,4
,5
]}

机构：

[1] Univ Utah, Sch Med, Div Rheumatol, Dept Med, Salt Lake City, UT 84112 USA

[2] ARUP Inst Clin & Expt Pathol, Salt Lake City, UT USA

[3] Univ Utah, Sch Med, Dept Pathol, Salt Lake City, UT 84112 USA

[4] Univ Utah, Sch Med, Dept Pediat, Salt Lake City, UT 84112 USA

[5] Univ Utah, Sch Med, Dept Med, Salt Lake City, UT 84112 USA

来源：

AMERICAN JOURNAL OF CLINICAL PATHOLOGY | 2011年 / 135卷 / 05期

关键词：

Antinuclear antibodies; HEp-2; immunofluorescence; ANA ELISA testing; ANA screening; Multiplexing; SYSTEMIC-LUPUS-ERYTHEMATOSUS; REVISED CRITERIA; LABORATORY TESTS; THROMBOCYTOPENIC PURPURA; CLINICAL-SIGNIFICANCE; DIAGNOSTIC-ACCURACY; HEALTHY-CHILDREN; CLASSIFICATION; PREVALENCE; AUTOANTIBODIES;

D O I：

10.1309/AJCP6R8EELGODAYW

中图分类号：

R36 [病理学];

学科分类号：

100104 ;

摘要：

The purpose of this study was to analyze antinuclear antibody (ANA) screening by enzyme-linked immunosorbent assay (ELISA) followed by indirect fluorescent antibody (IFA) testing to confirm and characterize the pattern and titer of the antibody. We evaluated 4 ANA ELISAs and 1 HEp-2 IFA substrate in 224 clinically defined serum samples consisting of 30 from systemic lupus erythematosus (SLE) cases, 94 from rheumatoid arthritis cases, and 100 from healthy donors plus 495 serum samples submitted for routine ANA testing and 12 reference serum samples distributed by the Centers for Disease Control and Prevention. IFA tests were read independently by 2 certified medical technologists. ELISA sensitivities ranged from 90% to 97% compared with 80% by IFA in the SLE serum samples. The ELISAs had specificities of 36% to 94%, whereas the IFA had 99% specificity. Overall, ELISAs for ANA assays demonstrated better sensitivity and good specificity, suggesting ELISA is a more cost-effective alternative to IFA testing for initial ANA screening. Samples positive by ANA ELISA should be tested on HEp-2 to determine the titer and pattern.

引用

页码：678 / 684

页数：7

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